Cases

Database lens care products Menicon

The SSA has collaborated with Menicon. Menicon is a manufacturer of so-called made-to-order contact lenses and these products fall under the Medical Device Regulation (MDR). The MDR is a new ruling, introducing stricter requirements on a wider scope. In the instruction for use (IFU) this means that the manufacturer has to dictate the advised care products for their lenses. The MDR basically expects that all lens care products available on the market are taken into account for this advice. To help tackle this problem a database has been set-up containing categorized lens care products based on their composition and function. This can help Menicon rationalize that untested products are similar to tested products. Consequently, their safety and efficacy can be determined based on a limited amount of products.

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